関連する実験動画
登録された糖尿病試験における患者にとって重要なアウトカム
Gunjan Y Gandhi1, M Hassan Murad, Akira Fujiyoshi
1Division of Endocrinology, Diabetes, Metabolism and Nutrition, College of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
JAMA
|June 5, 2008
まとめ
ほとんどの糖尿病臨床試験では,患者にとって重要な結果に優先順位を付けていません. 登録されたランダム化臨床試験 (RCT) のわずか18%が,患者にとって重要なアウトカムを主な焦点として使用し,安全性と有効性の評価に影響を与えた.
科学分野:
- 臨床研究の方法論 臨床研究の方法論
- 糖尿病の介入方法 糖尿病の介入方法
- 患者中心のアウトカムに関する研究結果
背景:
- 糖尿病介入の安全性と有効性に関する懸念は依然として残っています.
- ランダム化臨床試験 (RCT) には,死亡率や生活の質などの患者にとって重要な結果の測定がしばしば欠けている.
研究 の 目的:
- 進行中のおよび将来の糖尿病RCTに患者にとって重要なアウトカムの含有率を体系的に評価する.
- 患者にとって重要なアウトカムを測定する糖尿病RCTの割合を決定する.
主な方法:
- 主要なRCTレジストリ (ClinicalTrials.gov,ISRCTN,ANZCTR) で適格な試験を検索しました.
- 糖尿病患者を対象とした436の2〜4期RCTを特定し,サンプルを採取し,2004年以降登録されたRCTに焦点を当てた.
- 独立したレビュー者は,研究特性と結果タイプ (患者重要,代理,生理学的) に関するデータを抽出しました.
主要な成果:
- 分析された436件のRCTのうち,患者にとって重要なアウトカムを主要アウトカムとして使用したのはわずか18%であった.
- 61%の治験では代理治療による結果が主であり,16%の治験では生理学的結果が主であった.
- 46%の試験で患者にとって重要なアウトカムがプライマリまたはセカンダリーとして報告されました. より大きく,より長い試験は,それらを含む可能性が高く,並列設計と2型糖尿病試験は,可能性が低い.
結論:
- 糖尿病に関する登録されたRCTの大多数は,患者にとって重要なアウトカムに優先順位を付けていません.
- この過小評価は,真の介入の有効性と患者の幸福度の評価を制限する可能性があります.
- 将来の研究と試験の設計は,患者にとって重要な結果を含むことを強調すべきである.
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